Quality Engineer II
$86,465–$116,728 year
On-siteSan Jose, California, United States
San Jose, California, United StatesOn-siteFull Time$86,465–$116,728 yearBachelors Degree
Full TimeBachelors Degree
Job Summary
Develop and establish documented procedures meeting customer and regulatory requirements, ensuring incoming goods inspections have clear specifications. Review and approve change control activities as the site Quality lead for Supply Chain, while managing MRB processes and handling NCRs with clear product disposition. Drive improvements for adherence to documented requirements and support or lead CAPA activities related to Supply Chain functions. Share complaint and repair data to alert Field Service and Asset Management where additional training or assistance is needed.
Required Qualifications
- Bachelor's Degree in Engineering or Scientific Discipline
- More than three (3) years of Engineering experience
- Minimum of 3 years of experience
- Strong written and verbal communication skills
- Ability to communicate clearly and present information concepts and ideas across all levels of the organization
- Strong interpersonal skills
- Ability to work effectively cross-functionally
- Ability to work with mathematical concepts such as probability and statistics
- Ability to organize, prioritize and schedule work assignments with some supervision
- Ability to solve practical problems
- Ability to work on multiple project tasks and assignments efficiently
- Basic understanding of 5S and other forms of waste elimination in the Production environment
- Working knowledge of ISO 13485
- Working knowledge of FDA Regulations
- Proficient in Microsoft Office
Desired Qualifications
- ASQ certification
- Ability to program in MS Excel
- Ability to program in MS Access
- Ability to program in SAP Business Objects
- Ability to program in other Database tools
- SAP
- Working Knowledge of Minitab Software
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